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Access to Primary CareNCT05484609

Access to Primary Care for People With Opioid Use Disorder

A study testing OUD scenario and Diabetes scenario in people with Access to Primary Care, run by Women's College Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a primary care provider. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Access to Primary Care
What is being tested?
OUD scenario and Diabetes scenario
Could I receive a placebo?
No, everyone receives an active treatment
How many people
383 participants
Where
1 siteCanada
Study dates
1 Jun 2021to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • physicians with an active, unrestricted, independent practice in Ontario with a self-reported specialty in Family Medicine

Who cannot join

  • physicians with restricted practices (e.g., could not prescribe opioids)
  • physician not in independent practice (i.e., physicians in training)
  • physicians whose practice address is in a community with a population less than 10,000, unless they are close (less than 50km) to a community with a population greater than 20,000.
  • physicians who do not provide primary care
  • physicians who require a health card number prior to offering a new patient appointment
  • physicians who require an in person visit prior to offering a new patient appointment
  • physicians who we are unable to reach after five phone calls and do not have voicemail
  • physicians who work at same practice address as another randomly-selected physician included in the study

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Province of Ontario

    Ontario, Ontario

Other trials in Canada

About this study

Official title: Examining Access to Primary Care for People With Opioid Use Disorder: a Randomized Controlled Audit Study

Background: Access to high quality primary care is essential for health, particularly for vulnerable populations. Research indicates, however, that people with opioid use disorder (OUD), are less likely than others to have a primary care provider. The reasons are unclear, but may be related to patient factors, system barriers and provider factors, including discrimination.

Research goal: Our primary goal is to determine if discrimination by primary care physicians plays a role in poor access to primary care for those in treatment for OUD. The answers will help researchers and policy-makers find ways to improve access to primary care for this vulnerable population.

Read more

Research question: Are people in treatment for OUD less likely to be offered a new patient appointment with a physician compared to those in treatment for diabetes? Overall study design: In this randomized controlled trial (RCT), the investigators will make unannounced phone calls to primary care physicians' practices to ask for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes, or a patient in treatment for OUD. Our outcome measure is an unconditional offer of a new patient appointment with the physician contacted or with another physician at the same practice. In an secondary analysis the investigators will determine the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment.

Participants: Randomly-selected primary care physicians in Ontario. Data analysis methods: The investigators will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.

Read the detailed description

Study context

According to the World Health Organization (WHO) primary health care is a "highly effective and efficient way to address the main causes and risks of poor health and wellbeing today" (1). Primary care is particularly important for vulnerable populations as it appears to mitigate effects from factors like low socioeconomic status (2-4). This appears to be true for those with opioid use disorder (OUD): in previous work, enrolment to a primary care physician was associated with higher rates of cancer screening and diabetes monitoring for those in treatment for OUD (5).

In universal health care systems, like Canada's, everyone is entitled to primary health care, regardless of health conditions or financial status. Our previous work, however, indicates that Ontarians in treatment for OUD are less likely to have access to primary care than others. Only 43% of people in treatment for OUD were enrolled with a primary care physician compared to 73% of matched controls (5). Our findings are consistent with an American study that reported poor access to primary care for those in treatment for OUD (6). These findings are concerning. Not only are those with OUD a vulnerable population with complex health needs, their numbers are also growing. OUD currently affects 15.5 million people worldwide (7), with Canada and the United States (U.S.) having the highest burden of disease (8).

Barriers to primary care for those with OUD have been poorly studied. Patient factors, such as difficulty attending appointments, and system barriers, like transportation costs, may affect access (9). Provider factors appear to play a role as well. A qualitative interview study in Ontario found that provider discrimination and stigma towards those with substance use disorder presented a barrier to accessing primary care (9). Other studies support this finding, showing that many providers, just like the general public, have stigma towards those with substance use disorder (10,11). It is possible that negative attitudes lead providers to discriminate against people with OUD when deciding whether to offer a new patient appointment.

Study rationale and goal

Our study goal is to determine if discrimination by physicians is a barrier to accessing primary care for those with OUD.

Research questions

  1. Are people in treatment for OUD less likely to be offered a new patient appointment compared to people in treatment for diabetes?
  2. What is the impact of physician gender, years in practice, rurality and model of care on offers of a new patient appointment?

Methods

The investigators will conduct a randomized controlled trial (RCT), using a similar approach to Olah et al that looked at access to primary care for those of low socio-economic status (14). They will make unannounced phone calls to primary care physicians in Ontario asking for a new patient appointment. Physicians will be randomly assigned to one of two clinical scenarios: a patient with diabetes treated by an endocrinologist, or a patient with OUD prescribed methadone by an addiction physician. In the secondary exploratory analyses, the investigators will also assess the impact of the model of care (team vs not), gender, rural vs urban, and years in practice.

Population The investigators will use information on the College of Physicians and Surgeon of Ontario (CPSO) website to identify all physicians in Ontario who have an active, independent, unrestricted practice with a self-reported speciality in family medicine (20).

Sample size calculation The objective of our study is to compare the proportion of patients offered a new patient appointment in each of the arms of the study. Our team consensus was that a 10% difference in the proportion of new patient appointments would be clinically meaningful. In a similar study design, Olah et al found that 23.5 % of those with diabetes were offered an appointment from a physician in Ontario (14). For our sample size calculation, the investigators assumed that 23% of those with diabetes and 13% of those in treatment for OUD would be offered a new appointment. At 80% power, 5% type-1 error level, to detect 10% difference in the proportion of new appointments offered between opioid (13%) and diabetes (23%) groups, would require 231 physicians with each scenario. However, previous studies using this approach found that up to one third of physicians were excluded at the time of making the phone call (because physician worked in a walk-in clinic or had a practice that was not primary care; or because of no response after five phone calls) (14,18). Therefore, the study should include 308 physicians in each arm.

To create our sample, the investigators will create a database using publicly-available information on the CPSO website. They will include all physicians who have an active, unrestricted, independent practice with speciality in Family Medicine. They will also record the physician's address(es), postal code, phone number(s), date of registration for independent practice and gender in our database. Physicians will only be identified in the database by a unique identifier. All these data items are collected by the CPSO. They will then group the physicians by primary practice address and then randomly select (using a random number generator), one physician from the list of physicians who work at the same site. The investigators will exclude other physicians from the same practice address.They will then use a random number generator to randomly select a statistical determined sample of physicians. We will randomly assign them to one of two clinical scenarios: a patient with diabetes treated by an endocrinologist, or a patient with OUD prescribed methadone by an addiction physician.

Scenarios The investigators will train a research assistant (RA) in the clinical scenario and pilot-test the interaction with a simulated receptionist giving different responses (see Appendix 1: Sample Script). To reduce confounding, they will have the same RA make all the phone calls. The RA will contact each physician to request an appointment, for one of the two clinical scenarios. The investigators will exclude physicians at the time of making the phone call if the physician's receptionist reports that the clinic is a walk-in, or that the physician does not offer primary care (14). They will also exclude practices at the time of making the call if they request an in person visit or health card number prior to making an offer of a new patient appointment. The investigators will attempt to reach a physician up to five times over a six-week period. For offices with voicemail, they will leave a message with the script but continue to make up to five phone calls to speak with someone in person. The investigators will accept call-backs up to six weeks after the initial phone call. They will exclude practices where they are not able to speak to anyone or leave a voicemail after five phone calls. They will only request an appointment once from a physician. If the physician's clinic offers an appointment, they will call the next day and cancel it. The investigators will continue sampling until they reach our target number of physicians.

Data analysis The investigators will use descriptive statistics to report on the population. To answer our research question, they will compare the proportion of patients offered a primary care appointment (a binary outcome) across the randomized groups. They will use chi-squared test and logistic regression to determine if there is a statistically and clinically significant difference in the proportions of offering a new patient appointment between the two clinical scenarios.

The investigators expect groups to be balanced on measured and unmeasured confounding variables. Nonetheless, they will investigate the distribution of measured variables across the two groups. If they observe imbalances, they will estimate the adjusted impact on the likelihood of being offered a new appointment, after controlling for possible confounding factors.

For our secondary analyses the investigators will use Fisher Exact test and two sample Wilcoxon test to assess if pre-specified subgroups: physician gender (male vs. female); practice location (rural < 50,000 vs. urban practice setting > 50,000); years in clinical practice, and practice model (team-based vs. not) affected the likelihood that a patient would receive an unconditional offer of a new patient appointment.

The investigators expect groups to be balanced on measured and unmeasured confounding variables. Nonetheless, they will investigate the distribution of measured variables across the two groups. If they observe imbalances, they will estimate the adjusted impact on the likelihood of being offered a new appointment, after controlling for possible confounding factors.

For our secondary analyses the investigators will use Fisher Exact test and two sample Wilcoxon test to assess if pre-specified subgroups: physician gender (male vs. female); practice location (rural < 50,000 vs. urban practice setting > 50,000); years in clinical practice, and practice model (team-based vs. not) affected the likelihood that a patient would receive an unconditional offer of a new patient appointment.

Being tested
OUD scenario, Diabetes scenario
Keywords
primary care, access to health care, opioid use disorder, addictions, health services
Medical subject headings
Opioid-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OUD scenarioOther

    The patient actor will make unannounced phone calls to family physicians asking for a new patient appointment. The patient actor will play the role of a patient with opioid use disorder undergoing methadone treatment with an addiction physician.

  • Diabetes scenarioOther

    The patient actor will make unannounced phone calls to family physicians asking for a new patient appointment. The patient actor will play the role of patient with diabetes in treatment with an endocrinologist.

Study groups in NCT05484609
Study groupRoleWhat they receive
OUD scenarioExperimentalNot described
Receives: Other: OUD scenario
Diabetes scenarioActive comparatorNot described
Receives: Other: Diabetes scenario

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with an offer of a new patient appointment

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start1 Jun 2021
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 allocation
Masking
None (open label)
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484609
Sponsor's protocol ID
410012447
Status last verified
Jul 2022
First submitted
27 Jul 2022
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers

Publications

  • Spithoff S, Mogic L, Hum S, Moineddin R, Meaney C, Kiran T. Examining Access to Primary Care for People With Opioid Use Disorder in Ontario, Canada: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2233659. doi: 10.1001/jamanetworkopen.2022.33659.

    PubMed 36178686

Questions about this trial

What is this clinical trial studying?

A study testing OUD scenario and Diabetes scenario in people with Access to Primary Care, run by Women's College Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with an offer of a new patient appointment (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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